Alarming conflicts of interest, other big red flags taint COVID vaccine approval process
March 17, 2021 (LifeSiteNews) — In the controversy surrounding the COVID-19 virus and vaccines — as with any controversy — the data you present to someone with an opposing opinion will, more often than not, have little effect on their opinion. There’s a good chance you know someone who has looked at the same reports, scientific commentary, and death counts that you have, but has reached completely different conclusions about the danger of the COVID-19 virus or vaccines.
So what does this issue really come down to? Trust.
I would argue that, especially now in the age of COVID-19, a natural default position is one of trust in one’s national health policy. Why would you not trust in a recommendation for a treatment that is being encouraged and supported by nearly every sector of government, from both parties, as well as from international health organizations and the mainstream media?
If one assumes that these groups are operating as intended — that is, that they are motivated by concern for public health, or at the very least, that they serve as checks and balances upon each other in the event of possible corruption — then even reports of deaths shortly following vaccination will not shake such a trust. They will be taken in stride as unfortunate but inevitable — albeit seemingly rare — accidents.
But what if the relationships between pharmaceutical companies and the government are so closely entangled that the integrity of the vaccine approval process is compromised? Is it possible that the influence of the pharmaceutical industry is so pervasive as to neutralize what would otherwise be a self-regulating system of checks and balances?
As unlikely as that may sound to some, a close examination of the conflicts of interest present in the COVID-19 vaccine approval process reveal glaring and disturbing problems that should cause us to question the trustworthiness — at the very least — of the process by which these vaccines have been “approved.”
Big Pharma: The fat cat of lobbyists
That the pharmaceutical industry throws around the weight of its massive wealth has been well documented, earning it the nickname “Big Pharma.” As Open Secrets reveals, the pharmaceutical industry is decidedly the top lobbying force in D.C. Big Pharma is so big, in fact, that pharmaceutical companies “spend more on lobbying than any other industry” and “spend twice what oil and gas spends. [They] have more lobbyists on Capitol Hill than all the congressmen and all the senators combined,” as Robert F. Kennedy Jr. explains.
And Big Pharma doesn’t just spend “big money” — it spends it everywhere.
“Captured agencies” set the stage
It is the wide, multi-pronged reach of Big Pharma’s money that deflates the power of what would otherwise serve as checks and balances on health policy. Kennedy Jr. explains, “Pharmaceutical companies [have] not only corrupted our politicians with huge amounts of lobbying money; They [have] captured the agencies that are supposed to protect Americans from public health threats: the CDC, the FDA, the HHS ... They had become sock puppets for the industries they were supposed to regulate. Kennedy goes so far as to claim, “The entire political structure today is saturated in pharmaceutical propaganda.”
In fact, even the first steps of our health regulatory process are tainted by the “tentacles” of Big Pharma in an incredible way. As the Federalist reported: “Few people recognize that most of the funding for [pharmaceutical] clinical trials comes from the pharmaceutical industry and that the industry deeply influences their conduct. Nor is it widely known that two-thirds of the Food and Drug Administration’s (FDA) budget for evaluating prescription drugs comes from the industry it regulates.”
These money ties set the stage for the COVID-19 vaccine approval process, and already raise some troubling questions. But the U.S. government’s efforts, specifically, to bring a COVID-19 vaccine to market as quickly as possible are fraught with yet more disturbing red flags.
Considering that the mRNA mechanism used in these vaccines has never before been deemed safe for public use, the question of the purity of intention behind its promotion is a matter of urgency.
Birth of Operation Warp Speed
The group charged with the selection, funding, and distribution of COVID-19 vaccines and treatments in the U.S. was Operation Warp Speed. It described itself as a public-private partnership that would “coordinate existing HHS-wide efforts” and involve government’s major branches, including the CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA).
While Operation Warp Speed was technically an initiative of the Trump administration, a significant number of the players involved clashed with the White House, as Politico revealed. In fact, White House Coronavirus Task Force members were reported to have been excluded from early Warp Speed discussions.
"We were blindsided by it," said a former White House official involved in the task force, according to Politico. "They wouldn’t brief the task force on it … [just] a private briefing."
Politico further reveals that Operation Warp Speed was really the brainchild of Health and Human Services secretary Alex Azar, “who was often at odds with the White House.”
In the lead-up to the birthing of Operation Warp Speed, “HHS officials convened a new advisory board for the secretary featuring the government’s top scientists” — including NIH Director Francis Collins, Anthony Fauci, the CDC’s Nancy Messonnier and others — “that met several times in early April, reviewing the initial development of Covid-19 treatments and vaccines,” reported Politico.
“By Monday April 13, the team had developed a PowerPoint presentation that described their ‘MP2’ [Manhattan Project 2] vision, and Azar met with White House senior adviser Jared Kushner to pitch him on the plan,” Politico continued.
“Kushner was ‘completely supportive’ of the project, Azar told POLITICO, and White House Chief of Staff Mark Meadows also threw his support behind the idea.” Azar subsequently began “quietly calling industry contacts to find potential drug-industry executives who could help steer the new initiative.”
Politico goes on to reveal that Azar later called government officials and “made the $3 trillion pitch,” in Azar’s own words.
“We should put everything we have against this. It should be a whole of government approach. We should build a board of directors that involves us. And we can declare a goal of January 1 for a vaccine and move against that,” Azar said of his vaccine plan, explaining that it had won unanimous approval.
What was formerly titled “Manhattan Project 2” became Operation Warp Speed. “HHS officials quickly moved forward on recruiting venture capitalist Moncef Slaoui as Warp Speed’s top scientific adviser and tapping other industry veterans like Carlo de Notaristefani to oversee the project’s manufacturing.”
While the problems with Operation Warp Speed were arguably rooted in Azar’s pharma-friendly strategy, they first materialized in the personnel picks for Warp Speed, beginning at the top.
Warp Speed’s chief scientist, Moncef Slaoui, was the former chairman for vaccines at GlaxoSmithKline, which “coincidentally” received the largest [contract] payout at the start of Operation Warp Speed. He had also, just prior to his appointment, served as a member of the board of directors of Moderna Therapeutics, which came to gain billions of dollars from its head start as maker of the second emergency-authorized COVID-19 vaccine.
Slaoui was criticized for continuing to hold more than $10 million worth of stock options in Moderna even after his Operation Warp Speed appointment, and he eventually sold those shares, to donate the value to cancer research.
However, he continued to hold just under $10 million in GlaxoSmithKline stock, and was reported to have joined Operation Warp Speed on the condition that he would not have to sell it.
“I have worked for 29 years for GSK,” Dr. Slaoui told the New York Times. “I have never sold a single share of any company in my life. This is my retirement. What I said regarding the GSK shares, I said I cannot take the job if I have to sell them.”
“People shouldn’t have to wonder if federal investments are going where they are needed most to develop a successful vaccine or if they are being handed out to boost the personal financial holdings of government contractors or as favors to friends of the Administration,” commented Eli Zupnick, spokesman for Patients Over Pharma.
Playing both sides
Even more troubling is the incredible role twist during Operation Warp Speed for Dr. Peter Marks, one of the single most influential figures during the COVID-19 vaccine rollout.
Marks was appointed to oversee the vaccines component of Operation Warp Speed. As such, he would have played a key role in choosing which vaccines the government selected and funded during Operation Warp Speed, as the recounting of government officials seems to affirm. Politico reported that “according to three people familiar with the event,” Marks’ “reticence was clear at the April 28 meeting of the White House coronavirus task force where Birx laid into Marks about the nation’s vaccine strategy.”
“Birx pressed Marks for clearer answers on which vaccines the government was working on or funding, and why it was not funding or studying others, said a fourth official familiar with the meeting.”
Why was Marks reported to have been “reticent” during this meeting? Perhaps the answer to this question sheds light on some of the current problems with COVID-19 vaccines.
Politico claims, “But the FDA's vaccine chief does not make those calls. Other scientists, including the chief of the Biomedical Advanced Research and Development Authority [BARDA], dictate key funding decisions.”
But indeed, at the time, Marks’ role was not FDA vaccine chief, but Operation Warp Speed vaccine chief. Operation Warp Speed says it would help coordinate work by BARDA. Are we to imagine that as vaccine chief, Marks had no say in which vaccines were being selected? Why would he be grilled about the questions of which vaccines they were funding?
Politico also revealed that during Operation Warp Speed planning meetings, Marks “argued for a sweeping effort to use the federal government’s powers and deep pockets, and officials openly discussed the idea of a [project] that would rush Covid-19 treatments and vaccines.” While discussing these meetings during an HHS podcast, Marks explained, “Sometimes, there are ways to eliminate dead space … you can eliminate time between things.”
It was in May 2020, shortly after Operation Warp Speed was launched, that Marks returned to his former role as chief regulator of vaccines at the FDA. In his official statement on the decision, released through the FDA press office and shared by Politico, he said, “I believe that the American public will be best served by my return full time to FDA, where I can continue to work collaboratively, with industry, government partners and other researchers and provide regulatory advice to expedite the development and availability of vaccines to combat COVID-19.”
This was a momentous turn of events. The man chosen to help select the vaccines that would be distributed nationwide to combat COVID-19, in an operation that was an openly “public-private partnership” — and who was involved in the push for hurried vaccine development — would now be the one in charge of deciding whether the vaccines were safe enough for public use.
The real kicker is that then-FDA Commissioner Stephen Hahn claimed in August that they had "drawn a very bright line at FDA between us and Operation Warp Speed because we’re the independent regulator. We can’t make those decisions about which vaccine to put forward, etc. We can only provide technical assistance.”
“What we can’t be and what we aren’t are the folks who are deciding who gets to develop moving forward. Operation Warp Speed uses federal dollars to actually decide which of the manufacturers of vaccine and therapeutics they’re going to choose to support,” Hahn continued.
Marks has discussed on FDA podcasts his role in helping to approve the COVID-19 vaccines as director of the Center for Biologics Evaluation and Research (CBER), which is “responsible for assuring the safety and effectiveness” of vaccines, among other products.
In one discussion, he reveals a troubling fact about the COVID-19 vaccine approval process. Because of the rushed deployment of the COVID-19 vaccines, they are skipping a “fourth stage of development” that ordinarily occurs; or rather, implementing it after the vaccine is approved.
“Sometimes it’s called phase four. But in this case, it’s what happens after the vaccine is approved, which is that sometimes we ask manufacturers to do additional work, to look in special populations, or we ask them to do studies, to look at even larger numbers of people to make sure that we really understand how the vaccine works in either specific populations or that we understand any specific side effects that we think might be associated with the vaccine,” said Marks.
“So, we will be making sure that after the vaccine is out there and getting used, any vaccine that we are keeping tabs on what’s happening in terms of its safety, we’ll be making sure that there aren’t some rare adverse events that pops up that we didn’t see before,” Marks continued.
Another red flag for Operation Warp Speed was the appointment of top FDA drug regulator Janet Woodcock to oversee COVID-fighting therapeutics (as opposed to vaccines).
Woodcock, who joined the FDA in 1986, is currently its Acting Commissioner and the director of the FDA’s Center for Drug Evaluation and Research (CDER), a position she has held since 2008, and before that, held from 1994 to 2004.
Because of her role as head of CDER, which is the FDA department responsible for approving new prescription opioids, she has been blasted for her part in the nation’s devastating opioid crisis. The Guardian reported that no less than 28 groups wrote a letter to the Biden administration in January accusing Woodcock of presiding over “one of the worst regulatory agency failures in US history.”
“In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter said.
“The letter accused Woodcock of ‘dereliction of duty’ for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing and spread of an epidemic that has claimed more than 500,000 lives,” according to the Guardian.
Even more damning were revelations that FDA officials “responsible for opioid approvals were taking part in ‘pay to play’ schemes where manufacturers paid tens of thousands of dollars to attend meetings to draw up the criteria for approving prescription narcotics.”
Dr. Raeford E. Brown, chairman of the FDA opioid advisory committee whose own recommendations have often been overruled, has claimed that there is a “war” within the FDA, and that their “lack of insight” “is in many ways a willful blindness that borders on the criminal.”
Woodcock’s approach to drug regulation also seems to be confirmed by her support of the 21st Century Cures Act, which was criticized as a “huge step backwards for patients” for loosening drug approval standards and allowing pharma companies to bypass randomized trials and even independent FDA analysis of drug studies.
Politico reported that Woodcock “raised strong concerns” during Operation Warp Speed regarding a proposal to track hydroxychloroquine use outside of clinical trials, saying “it would promote off-label prescriptions of hydroxychloroquine without proof the drug was safe or effective for coronavirus patients.”
Considering that hydroxychloroquine has been approved for use without restriction by the FDA for over 65 years, as well as her abysmal track record at the FDA, one wonders whether Dr. Woodcock is driven by commitment to public health, or loyalty to Big Pharma.
Even more causes for alarm in the vaccine approval process are revealed upon a closer look at the first two pharma companies to bring a COVID-19 “vaccine” to market, and gain billions of dollars through their head start: Pfizer and Moderna.
Pharma giant partners with company backed by Gates Foundation
The first company to have a COVID-19 approved for emergency use by a so-called “stringent regulatory authority” — Pfizer — which came in close second to Sanofi/GlaxoSmithKline for the largest contract payouts awarded in Operation Warpspeed — is distinguished among pharma companies for spreading the wealth among public officials.
As OpenSecrets.org reveals, Pfizer was the top pharma contributor by a wide margin to political candidates and parties during the 2020 election cycle, donating a total of $3,279,380. Open Secrets lists a total of 853 recipients of that [largesse], with Joe Biden topping the list as their greatest beneficiary, followed by the Democratic Senatorial Campaign Committee and the DNC Services Corp. The long list of their beneficiaries also includes Donald Trump, congressional campaign committees of both parties, congressmen, mayors, state party groups, and a variety of PACs.
Might this be why the company is so favored, despite its being among the “convicted serial felons” of pharmaceutical companies?
While it’s not unreasonable to say that Pfizer’s lavish spending laid the “groundwork for its November 20 filing for Emergency Use Authorization for its coronavirus vaccine” (Chander, 2020; Children’s Health Defense, 2020), as The Children’s Health Defense noted, Pfizer had another advantage in the race to market.
Pfizer had already partnered with BioNTech to develop mRNA-based vaccines for influenza in August 2018, and in September 2019, the Bill & Melinda Gates Foundation invested $55 million in BioNTech to develop HIV and tuberculosis programs. The foundation praised BioNTech for its “innovative mRNA-based approach.”
This primed BioNTech to get a head start developing an mRNA COVID-19 vaccine at “lightspeed” in mid-January of 2020, just days after the virus’s genetic sequences were released.
What is noteworthy here is that the development of an mRNA-based flu vaccine never passed the preclinical trial phase — nor have most of BioNTech’s mRNA-based treatments, as one observes in the “product pipeline” section of the BioNTech website. In fact, aside from their COVID-19 mRNA “vaccine,” only one other mRNA treatment has passed Phase 1 of clinical trials. This is after a few years of having research results on mrNA mechanisms published by BioNTech, which was founded in 2008.
Since the Pfizer mRNA vaccine has been authorized for public use, numerous deaths have been reported to have occurred shortly following vaccination. One German whistleblower, for example, reported that seven of 31 nursing home residents with dementia died shortly after their Pfizer vaccination.
Uncanny timing for NIH fortune
There is another enormous conflict of interest that raises questions about the approval of the second mRNA COVID-19 vaccine to come to market, developed by Moderna. In fact, the Moderna vaccine was being prepared by a government-pharma partnership even before COVID-19 was sequenced.
“According to Public Citizen, the National Institutes of Health (NIH) owns a 50% stake in Moderna’s mRNA-1273 vaccine, which it helped develop under the National Institute of Allergy and Infectious Diseases (NIAID), run by Dr. Anthony Fauci,” reported CHD.
Axios reported that “NIH and Moderna have researched coronaviruses, like MERS, for several years,” and that they signed a contract in December 2019 “that stated ‘mRNA coronavirus vaccine candidates [are] developed and jointly owned’ by the two parties. The contract was not specific to the novel coronavirus, and it was signed before the new virus had been sequenced.
The first signature of the agreement is dated December 12, 2019, which was only four days before the first documented hospital admission due to COVID-19, and weeks before the virus outbreak was publicized.
NIH Director Francis Collins confirmed during an Economic Club interview in May, “We do have some particular stake in the intellectual property” behind Moderna's coronavirus vaccine.
“Little known NIH regulations let agency scientists collect up to $150,000.00 annually in royalties from vaccines upon which they worked,” CHD reported. “These rules are recipes for regulatory corruption.”
What Moderna has in common with BioNTech is that it has failed to prove the safety and efficacy of its mRNA candidates during the whole span of its work with mRNA treatments.
As of May 2020, only one of its mRNA candidates had passed Phase 1 trials, and not one had been brought to market since 2013, when it signed an agreement with AstraZeneca to develop and commercialize mRNA therapeutic treatments.
StatNews noted in 2016 that mRNA-based treatments are “highly risky,” and that “[b]ig pharma companies had tried similar work and abandoned it because it’s exceedingly hard to get RNA into cells without triggering nasty side effects.”
“Novartis abandoned the related realm of RNA interference over concerns about toxicity, as did Merck and Roche,” StatNews continued.
These difficulties with mRNA treatments, as well as NIH’s stake in Moderna’s COVID-19 vaccine and the rush to bring COVID-19 treatments to market, may explain why Fauci has allowed Moderna to skip animal trials, allowing the vaccine process that typically “can take 15 to 20 years, start to finish,” to be compressed into mere months, Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat News in March 2020.
CHD has since reported on discrepancies in Moderna’s COVID-19 vaccine trial, saying that while Moderna had claimed a 94.5 percent efficacy rate, when additional cases of COVID-19 occurring between the first and second shot were accounted for, the efficacy rate was shown to be 75.4 percent.
In addition to the evidence, as well as VAERS reports of numerous deaths shortly following the Moderna vaccine, The Defender reported that California was forced to recall a batch of 330,000 Moderna vaccines after a cascade of reported injuries, though now the company says it’s okay to resume administration of that batch.
With all these things considered, the question is: Can a COVID-19 vaccine approval process marked by such egregious and numerous conflicts of interest refrain from compromising public health and safety?